Tool member cover and cover deployment device

ABSTRACT

A surgical instrument including a tool member cover and a cover deployment device are disclosed. The cover is supported adjacent to or on the tool assembly of the surgical instrument and is movable from a first position in which the tool assembly is uncovered to a second position in which the tool assembly is at least partially encompassed by the cover. The deployment device is provided for moving the cover from the first position to the second position.

CROSS REFERENCE TO RELATED APPLICATIONS

This present application claims the benefit of and priority toInternational application Ser. No. PCT/US2003/024201 filed on Jul. 31,2003, which, in turn, claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/400,328, filed on Jul. 31, 2002, theentire contents of which are incorporated herein by reference.

BACKGROUND

1. Technical Field

This application relates to a cover and cover deployment device for thetool member or tool assembly of a surgical instrument, and moreparticularly, to a cover and cover deployment device for the tool memberof a laparoscopic or endoscopic surgical instrument for manipulating,treating or excising tissue, especially diseased or cancerous tissue,from a body cavity.

2. Background of Related Art

A variety of different types of surgical instruments have been developedfor manipulating, identifying, treating, repairing and/or excisingtissue including organs or portions thereof located within body cavitiessuch instruments sometimes being hereafter referred to as surgicalinstruments for treatment of body tissues. These instruments includegraspers, fasteners, e.g., staplers, dissectors, biopsy devices,coagulators, etc. Typically, these instruments are dimensioned to beused in both open and laparoscopic or endoscopic procedures.

In endoscopic surgical procedures for treatment of body tissue, asurgical instrument is inserted through an incision or cannula to aposition adjacent the tissue to be treated. The distal tool member ofthe instrument is then manipulated to treat, i.e., biopsy, excise,dissect, coagulate, reposition, etc., the tissue. Thereafter, theinstrument with or without excised tissue is withdrawn from the surgicalsite through the incision to remove the instrument from the body cavity.

One problem associated with current surgical devices is that duringremoval of the tool member from the surgical site, the tool member ortool assembly (hereafter, for simplicity “tool member”) of the surgicalinstrument for treating, for example, diseased, tissue comes intocontact with the healthy tissue defining the incision and/or within thebody cavity in which the surgical site is located. This may also be aproblem in open surgical procedures. Where the tissue being treated isdiseased tissue, e.g., cancerous, this problem becomes critical sincecontact between the cancerous tissue and the healthy tissue may resultin seeding of cancerous cells resulting in metastases.

Accordingly, a need exists in the art for improved instrumentation forshielding healthy tissue from diseased tissue during removal of asurgical instrument from a surgical site.

SUMMARY

The present disclosure provides a tool member cover for use with asurgical instrument having a tool assembly and a body portion. The coveris preferably tubular and has open distal and proximal ends. A portionof the cover, preferably the distal end, is fastened to the surgicalinstrument adjacent to or on the tool assembly. Alternately, the covermay be removably attached to the surgical instrument. The cover ismovable from a first position in which the tool member is uncovered to asecond position in which the cover at least partially encompasses thetool member.

Preferably, the cover is formed of an impermeable material. A deploymentdevice is provided for moving the cover from the first position to thesecond position. In a first embodiment, the deployment device includes asleeve formed of half-sections which are held together using expandablemembers, e.g., resilient O-rings. The O-rings allow the sleevehalf-sections to move outwardly relative to each other to allow thesleeve to pass over a tool assembly having a larger diameter than a bodyportion of the surgical instrument. The sleeve is slidably positionedabout the body of a surgical instrument between retracted and advancedpositions to move the cover from the first position to the secondposition. The cover is positioned about the body portion of the surgicalinstrument and about the deployment device such that when the deploymentdevice is moved from the retracted to the advanced position, the distalend of the sleeve engages the distal end of the cover to invert thecover over the tool assembly.

The cover may include a closure device such as a drawstring or elasticband to close the distal end of the cover to enclose the tool memberwithin the cover. The cover may be used with a variety of differenttypes of surgical instruments including staplers, fasteners,manipulators, biopsy devices, retractors, coagulators, dissectors etc.

BRIEF DESCRIPTION OF THE DRAWINGS

Various preferred embodiments of the presently disclosed tool membercover and cover deployment device are described herein with reference tothe drawings, wherein:

FIG. 1 is a perspective view of one preferred embodiment of thepresently disclosed tool member cover and cover deployment device, withparts separated, positioned about an unapproximated circular surgicalstapler;

FIG. 2 is a side perspective view of the deployment device sleeve withparts separated of the deployment device shown in FIG. 1;

FIG. 3 is a side perspective view of the deployment device sleeve shownin FIG. 2;

FIG. 4 is a perspective cutaway view of the distal end of the deploymentdevice sleeve shown in FIG. 3 fastened together with an O-ring;

FIG. 5 is a perspective view of the deployment device shown in FIG. 3positioned about the body portion of an unapproximated circular surgicalstapler with the sleeve halves in an expanded configuration;

FIG. 6 is a side perspective view of the deployment device of FIG. 5 ina contracted configuration, shown positioned about the body portion ofan unapproximated circular surgical stapler;

FIG. 7 is a side perspective view of the tool member cover and coverdeployment device of FIG. 1 positioned about the body portion of anunapproximated circular surgical stapler with the cover and deploymentdevice in a retracted position and the deployment device in a contractedconfiguration;

FIG. 8 is a side perspective view of the tool member cover and coverdeployment device of FIG. 7 positioned about the body portion of anapproximated circular surgical stapler with the cover and deploymentdevice in a retracted position and the deployment device in a contractedconfiguration;

FIG. 9 is a side perspective view of the tool member cover and coverdeployment device of FIG. 7 positioned about the body portion and toolassembly of a circular surgical stapler with the cover and deploymentdevice in a partially advanced position and the deployment device in anexpanded configuration;

FIG. 10 is a side perspective cutaway view of the tool member coverdeployed about the tool member of an approximated circular surgicalstapler;

FIG. 11 is a side perspective view of another preferred embodiment ofthe presently disclosed cover deployment device;

FIG. 12 is a side perspective view with portions broken away of thecover deployment device shown in FIG. 11 supported on a body portion ofan unapproximated circular surgical stapler;

FIG. 13 is a side perspective view with portions broken away of the toolmember cover and cover deployment device shown in FIG. 12 supported on abody portion of an unapproximated circular surgical stapler with thedeployment device and cover in retracted positions;

FIG. 14 is a side perspective view of the cover deployment device shownin FIG. 1 positioned about the body portion of endoscopicgastrointestinal anastomosis linear stapler;

FIG. 15 is a side perspective view with portions broken away of anotherpreferred embodiment of the tool member cover and the cover deploymentdevice shown in FIG. 1 positioned about the body portion of theendoscopic gastrointestinal anastomosis linear stapler of FIG. 15 andwith the cover and deployment device in retracted positions;

FIG. 16 is a side perspective view of the tool member cover in adeployed configuration positioned about the tool member of theendoscopic gastrointestinal intestinal anastomosis linear stapler ofFIG. 15;

FIG. 17 is a side perspective view of the cover deployment device shownin FIG. 1 positioned about the body portion of an ultrasonic dissectiondevice;

FIG. 18 is a side perspective view of the tool member cover and coverdeployment device shown in FIG. 1 positioned about the body portion ofthe ultrasonic dissection device of FIG. 17 with the tool member coverand deployment device in retracted positions; and

FIG. 19 is a side perspective view of the tool member cover in adeployed configuration about the tool member of the ultrasonicdissection device of FIG. 18.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed tool member cover andcover deployment device will now be described in detail with referenceto the drawings in which like reference numerals designate identical orcorresponding elements in each of the several views.

FIG. 1 illustrates one preferred embodiment of the presently disclosedtool member cover and cover deployment device. Briefly, tool membercover 10 includes a collapsible flexible material which is preferablyliquid impermeable and formed from one or more layers of a suitableplastic, preferably, polyethylene. Alternately, other liquid impermeablematerials, woven or non-woven, natural or synthetic, and suitable forsurgical use may be used to construct the cover, e.g., rubber,elastomers, polytetrafluroethylene, etc. Cover 10 is preferably tubularand defines a lumen 12 dimensioned or configured to receive the bodyportion 58 of a surgical instrument 11. Preferably, but not necessarily,the distal end 10 a of cover 10 has a smaller diameter than the proximalend of cover 10. A portion of cover 10 is preferably fastened to thesurgical instrument. The distal end 10 a of cover 10 is dimensioned orconfigured to be fastened directly onto or adjacent to a tool member 52or a shaft that adjoins a tool member or a handle of a surgicalinstrument 11. Alternately, cover 10 may have a constant diameter alongits entire length or the proximal end of cover 10 may have a smallerdiameter than the distal end of cover 10. Cover 10 is preferablyfastened to the surgical instrument in a liquid impermeable manner.Cover 10 may also be removably attached to the surgical instrument.

Referring also to FIGS. 2-4, cover deployment device 14 (FIG. 5)includes a sleeve 16 formed of sleeve half-sections 16 a and 16 b.Sleeve half-section 16 a includes a pair of extensions 18 which aredimensioned to be slidably received within slots 20 formed in sleeve 16b. Each sleeve half-section 16 a and 16 b includes a proximal end 22having a flange or semi-annular ring 24, a centrally positionedsemi-annular recess 25, a distally positioned semi-annular recess 26 anda proximally positioned semi-annular recess 27. The distal end 28 ofeach sleeve 16 a and 16 b includes a semi-annular blunt protrusion 30.The function of protrusion 30 will be discussed in detail hereinbelow.

Referring to FIGS. 2-4, sleeve half-sections 16 a and 16 b arepositioned in abutting relationship, with extensions 18 slidablypositioned in slots 20 to define a lumen 32 dimensioned to slidablyreceive or be positioned about a portion of the body of surgicalinstrument 11. An expandable member, preferably resilient O-ring 34(FIG. 1), is positioned in each of annular recesses 25, 26 and 27.O-rings 34 are stretchable from a contracted position to an expandedposition to allow sleeve half-sections 16 a and 16 b to move in relationto each other between contracted and expanded positions (FIGS. 3, 4 and9, respectively). In the contracted position, sleeves 16 a and 16 b arepreferably held in abutting relation with extensions 18 fully insertedwithin slots 20.

Referring to FIG. 5, sleeve half-sections 16 a and 16 b are configuredto be easily assembled about the elongated body portion 58 of surgicalinstrument 11 such that the distal end 28 of sleeve 16 is positionedadjacent a tool assembly 52 of surgical instrument 11. Although surgicalinstrument 11 is illustrated as a circular stapler, it is envisionedthat the surgical instrument may be any of a wide variety of instrumentsfor performing a wide variety of functions including cutting, fastening,manipulating, treating, dissecting, coagulating and biopsing tissue.Such instruments include retractors, biopsy devices, dissectors,coagulators, fasteners, staplers, including linear staplers, circularstapler, semi-circular staplers, arc shaped staplers, etc.

Referring also to FIGS. 6 and 7, in the illustrated embodiment, circularstapler 11 includes an unapproximated tool assembly 52 having an anvil54, a shell assembly 56 and an elongated body 58. One known circularstapler is disclosed in PCT application Serial No. PCT/US02/10792, whichis incorporated herein in its entirety by reference. Sleeve 16 isexpandably and slidably positioned about elongated body 58 such thatprotrusion 30 is positioned adjacent to shell assembly 56. The distalend 10 a of cover 10 is preferably secured adjacent to or on theproximal portion of tool assembly 52 at a fastening point or securement60 (FIG. 7) using a known fastening technique, e.g., adhesion, fusion,crimping, pins, clips etc. and is positioned about sleeve 16 and bodyportion 58 of surgical instrument 11. Alternately, cover 10 may bereleaseably secured to the instrument using known techniques includingsprings, tabs, hooks, etc. Annular protrusion 30, which is formed at thedistal end 28 of sleeve 16, is positioned proximally of fastening pointor securement 60.

It is understood that cover 10 can be secured at any suitable locationalong shaft 58, although on some instruments securing it close to oreven on the tool member itself will save cover material and will renderthe cover easier to manipulate with or without tissue therein.

Referring to FIGS. 8-10, in the illustrated embodiment, the distal end10 a of cover 10 is fastened to the proximal portion of shell assembly56 of tool assembly 52. In use, surgical instrument 11 is positionedsuch that tool assembly 52 is located adjacent the surgical site. Duringan endoscopic surgical procedure, this would include inserting the toolassembly 52 and a portion of body portion 58 through an incision withcover 10 and cover deployment device 14 supported about elongated bodyportion 58 of surgical instrument 11. Thereafter, the surgicalinstrument is manipulated to perform its associated or designedfunction. With respect to a circular stapler, body tissue (not shown) ispositioned between an unapproximated anvil 54 and shell assembly 56using, for example, a purse string suture (not shown). Next, the anvil54 and shell assembly 56 are approximated and surgical instrument 11 isfired in a known manner to dissect tissue and apply a circular array ofstaples to the dissected and remaining tissue. After surgical instrument11 has performed its associated function but prior to removal of toolassembly 52 from the surgical site, annular ring 24 of sleeve 16 ispushed forward manually, mechanically, remotely, or robotically in thedirection indicated by arrows “A” in FIG. 9 to advance sleeve 16 aboutbody 58 of surgical instrument 11. As sleeve 16 is advanced, annularprotrusion 30 engages distal end 10 a to invert cover 10 aboutsecurement 60 and gradually about cover 10 proximally of secured orattached tool assembly 52. Annular protrusion 30 includes a smooth orblunt surface to prevent tearing of cover 10 during advancement. Becausetool assembly 52 has a diameter larger than body 58, at least the distalend portions of sleeve half-sections 16 a and 16 b expand outwardly inrelation to each other by stretching O-rings 34 as distal end 28 ofsleeve 16 rides over tool assembly 58. It is noted that in surgicalinstruments having a tool assembly having a diameter equal to or lessthan the diameter of the body of the surgical instrument, stretchableo-rings would not be required. When sleeve 16 has been advanced to fullydeploy cover 10 about and preferably beyond tool assembly 52 (FIG. 10),the cover deployment device can be withdrawn to its retracted positionabout body 58 of surgical instrument 11. Surgical instrument 11including tool assembly 52 and incised tissue therein or thereabout (notshown) and enclosed by cover 10 can now be withdrawn from the surgicalsite without exposing the healthy tissue defining the incision andwithin the body cavity (not shown) to diseased tissue on or in the toolassembly.

FIGS. 11-13 illustrate another preferred embodiment of the presentlydisclosed cover deployment device shown generally as 116. It is notedthat the deployment devices disclosed herein are only exemplaryembodiments. Any suitable deployment device capable of positioning acover over a tool assembly of a surgical instrument after it has beenused in a surgical procedure is within the scope of this disclosure.Cover deployment device 116 includes a semi-rigid body portion 122having a proximal semi-annular guide portion 124 and a distalsemi-annular engagement member 126. Semi-annular engagement member 126is preferably formed of a sufficiently, diametrically and radiallyresilient material and is configured and dimensioned to engage theproximal end of a tool assembly 152 of a surgical instrument 111.Proximal guide portion 124 is configured to partially encompass bodyportion 158 of surgical instrument 111 and to be pushed by a surgeon tooperate deployment device 116. Body portion 122 of deployment device 116interconnects guide portion 124 and engagement member 126 and issufficiently rigid to transfer the imparted pushing force to theengagement member 126.

The distal end 110 a of cover 110 is secured to surgical instrument 111adjacent to or on a proximal portion of tool assembly 152 in the mannerdescribed above with respect to cover 10, such that cover 110 ispositioned about deployment device 116 and body 158 of surgicalinstrument 111. Engagement member 126 is positioned slightly proximallyof a fastening point 160 of cover 110 and to tool assembly 152. In use,deployment device 116 is advanced about body 158 of surgical instrument111 by pushing on guide portion 124 to advance engagement member 126into the distal end of cover 110 to invert cover 110 about tool assembly152 in a manner similar to that disclosed above. Because engagementmember 126 is flexible, it is able to slide over the increasing diameterof tool assembly 152. After cover 110 is fully deployed (not shown),deployment device 116 can be retracted and surgical instrument 111 canbe removed from a surgical site.

It is to be noted that the distal end 110 a of cover 110 can be securedto tool assembly 152 or a similar or like operating end to endanastomosis device that does not require holes such as “H” (FIG. 12) tovent directly to the atmosphere.

FIGS. 14-16 illustrate another preferred embodiment of tool assemblycover 210 and cover deployment device 214 including sleeve 216positioned about a body portion 258 of an endoscopic gastrointestinalanastomosis linear stapler 211. Such a stapler is described in detail inU.S. Pat. No. 6,241,139 which issued on Jun. 5, 2001 and is incorporatedherein in its entirety by reference. The cover deployment device 216 issubstantially identical in structure and use as the deployment devicedescribed in FIGS. 1-10 and will not be described in further detailherein. Cover 210 is substantially identical to cover 10 described abovebut further includes an elastic band 226 formed about, within orintegrally with a central portion of cover 210. Cover 210 is deployed ina manner substantially identical to that disclosed above. However, asshown in FIG. 16, when elastic band 226 is forced over the distal end oftool assembly 252 of surgical instrument 211, elastic band 226 contractsto close cover 210 about tool assembly 252. The enclosed bag preventstissue and/or body fluids from escaping cover 210 and infecting healthytissue in the body cavity or in the incision. It is noted that one ormore elastic band(s) 226 may be employed with or incorporated into anyof the covers disclosed herein.

FIG. 17-19 illustrate tool assembly cover 10 and cover deployment device14 shown in FIGS. 1-6 positioned about body 358 of an ultrasonicdissector instrument 311. Such an instrument is disclosed in U.S. Pat.No. 6,024,750 which issued on Feb. 14, 2000 and is incorporated hereinin its entirety by reference. As illustrated, cover 10 is preferablyfastened to the distal end of elongated body 358 of instrument 311proximally of a tool assembly 352 of instrument 311 such that when cover10 is deployed, in the manner discussed above with respect to FIGS. 1-6,tool assembly 352 and/or contaminated or treated tissue is encompassedby cover 10 (FIG. 19).

While the invention has been particularly shown and described withreference to the preferred embodiments, it will be understood by thoseskilled in the art that various modifications and changes in form anddetail may be made therein without departing from the scope and spiritof the invention. For example, a closure device other than an elasticband may be provided to close the cover about the tool assembly. Forexample, a drawstring “D” (FIG. 10) may be provided which can be graspedat the surgical site using graspers to close the cover 10 or thedrawstring may be fed through the surgical instrument and be accessiblefrom the proximal portion of the surgical instrument. Further, the coverneed not be inverted about the tool assembly but rather may be sliddirectly over the tool assembly. Also, the cover may be configured tonot only encompass the tool assembly but may also be configured toencompass a distal portion or the entire body portion of the surgicalinstrument. Accordingly, modifications such as those suggested above,but not limited thereto, are to be considered within the scope of theinvention.

What is claimed is:
 1. A surgical instrument comprising: a body portion;a tool assembly supported on the distal end of the body portion; anelongated cover supported about the body portion of the instrument, theelongated cover being formed from a collapsible material and having asubstantially tubular configuration having open proximal and distalends, the elongated cover being movable about the body portion of theinstrument from a first position located proximally of the tool assemblyto a second position at least partially encompassing the tool assembly,wherein when the elongated cover is in the first position the distal endof the elongated cover is secured to the instrument adjacent to the toolassembly such that the elongated cover can be inverted about the toolassembly as the elongated cover is moved from the first position to thesecond position; and a cover deployment device at least partiallydisposed about the body portion between the body portion and theelongated cover when the elongated cover is in the first position, thecover deployment device being in releasable engagement with the coverand being advanceable along the body portion to move the cover from thefirst position to the second position.
 2. A surgical instrumentaccording to claim 1, wherein the cover is liquid impermeable.
 3. Asurgical instrument according to claim 1, wherein the cover deploymentdevice includes a sleeve slidably positioned about the body portionbetween a retracted and an advanced position, the sleeve being slidablefrom the retracted position to the advanced position to move the coverfrom the first position to the second position.
 4. A surgical instrumentaccording to claim 3, wherein the sleeve includes first and secondhalf-sections, the first and second half-sections being urged intoabutment with one another by at least one expandable member, theexpandable member being expandable to permit the first and secondhalf-sections to move outwardly with respect to each other.
 5. Asurgical instrument according to claim 4, wherein the expandable memberis a resilient O-ring.
 6. A surgical instrument according to claim 4,wherein the sleeve includes a proximally located annular ringdimensioned to facilitate movement of the sleeve between the retractedand advanced positions.
 7. A surgical instrument according to claim 4,wherein the first sleeve half-section includes at least one projectionand the second sleeve half-section includes at least one slot, the atleast one projection being slidable into the at least one slot tomaintain alignment between the first and second half-sections when thehalf-sections move outwardly with respect to each other.
 8. A surgicalinstrument according to claim 1, wherein the cover defines a lumen andthe cover is positioned about the body portion and the cover deploymentdevice, wherein movement of the cover deployment device from theretracted position to the advanced position inverts the cover over thetool assembly.
 9. A surgical instrument according to claim 8, whereinthe cover deployment device includes a distal engagement member, aproximal guide portion and a central body portion interconnecting theengagement member and the guide portion, the cover deployment devicebeing slidably supported on the body portion to enable the coverdeployment device to be moved to move the cover to the second position.10. A surgical instrument according to claim 1, wherein the coverdefines a lumen, the proximal end of the cover being movable over thetool assembly to at least partially encompass the tool assembly.
 11. Asurgical instrument according to claim 10, further including a closuredevice for closing the proximal end of the cover after it has moved overthe tool assembly.
 12. A surgical instrument according to claim 11,wherein the closure device includes an elastic band supported by thecover.
 13. A surgical instrument according to claim 11, wherein theclosure device includes a drawstring.
 14. A surgical instrumentaccording to claim 13, wherein the distal end of the cover is removablyfastened to the surgical instrument.
 15. A surgical instrument accordingto claim 14, wherein the surgical instrument is a circular stapler. 16.A surgical instrument according to claim 14, wherein the surgicalinstrument is an ultrasonic dissector.
 17. A surgical instrumentaccording to claim 14, wherein surgical instrument is a linear stapler.18. A method of performing a surgical procedure comprising the followingsteps: providing a surgical instrument including a body portion, a toolassembly, a cover deployment device and a cover, the distal end of thecover being secured about the instrument adjacent a proximal end of thetool assembly, the cover deployment device being positioned on the bodyportion and the cover being positioned about the cover deployment devicesuch that the cover is movable from a first position wherein the toolassembly is uncovered to a second position wherein the tool assembly isat least partially covered by advancing the cover deployment devicealong the body portion; positioning the surgical instrument adjacent asurgical site and performing a surgical operation on desired tissue;moving the cover from the first position to the second position byadvancing the cover deployment device to invert the cover at leastpartially over the tool assembly; and subsequently removing the surgicalinstrument from the surgical site, while maintaining the cover at leastpartially over the tool assembly.
 19. A method according to claim 18,wherein the surgical instrument is a circular stapler.
 20. A methodaccording to claim 18, wherein the surgical instrument is a linearstapler.
 21. A method according to claim 18, wherein the surgicalinstrument is an ultrasonic dissector.
 22. A method according to claim18, wherein the surgical instrument includes a closure device, andfurther including the step of actuating the closure device to close thecover at a location distally of the tool assembly.
 23. A methodaccording to claim 22, wherein the closure device is a drawstring.